US20060129064A1 - Blood collection set with an expanded internal volume - Google Patents

Abstract

The blood collection set includes an IV needle assembly, a length of flexible plastic tubing extending from the IV needle assembly and a non-patient needle assembly. The set is formed with an internal chamber that increases the internal volume of the blood collection set. Thus, the increase in internal volume allowing for greater flash visualization on venous entry.

Description

• This application claims priority to U.S. Provisional Application No. 60/631,515, which was filed on Nov. 29, 2004.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The subject invention relates to a blood collection set with an internal chamber, which increases the internal volume of the blood collection set thereby improving flash.
• 2. Description of the Related Art
• Phlebotomy procedures often are carried out using a blood collection set. A typical blood collection set includes an IV needle assembly with an IV cannula that has a proximal end, a sharply pointed distal end and a lumen extending between the ends. The needle assembly also includes a plastic IV hub with a proximal end, a distal end, and a passage extending between the ends. The proximal end of the IV cannula is mounted in the passage of the IV hub so that the lumen through the IV cannula communicates with the passage through the IV hub. The needle assembly may further include a shield for shielding the IV cannula after use (a so called safety blood collection set) and a packaging cover for safely covering the IV cannula prior to use. Packaging covers typically are rigid tubes with a proximal end that can be telescoped over the IV cannula and frictionally engaged with the distal end of the IV hub. Shields for shielding the IV cannula of blood collection sets have taken many forms. Some shields are telescoped over the IV hub and can be moved from a proximal position where the cannula is exposed to a distal position where the cannula is shielded. Other shields are hinged to the IV hub and can be rotated from an open position where the IV cannula is exposed to a closed position where the IV cannula is shielded. A needle assembly for a blood collection set also may include two flexible wings that project transversely from the IV hub or from the shield. The wings can be folded into face-to-face relationship with one another to effectively define a handle that facilitates manipulation of the needle assembly. The wings then can be rotated away from one another and held against the skin of the patient.
• Blood collection sets also include a length of flexible plastic tubing. The tubing has a distal end that is connected to the proximal end of the IV hub. The tubing also has a proximal end that is connected to a plastic fitting. Thus, fluid communication is provided between the lumen of the IV cannula and the plastic fitting at the proximal end of the flexible tubing. The plastic fitting may be a female luer fitting that can be connected to a male luer fitting. The fitting then can be placed in communication with a reservoir or container for collecting a sample of blood.
• Phlebotomy procedures often employ evacuated tubes, such as the VACUTAINER® brand of evacuated tubes sold by Becton Dickinson and Company. Evacuated tubes often are used with a tube holder that has a proximal end, a distal end, and a tubular side wall extending between the ends. The proximal end of the holder is widely open and is configured for slidably receiving the evacuated tube. The distal end of the holder typically includes an end wall with a mounting aperture. The mounting aperture includes internal threads or other mounting structures.
• The tube holder may be used with a non-patient needle assembly that has a non-patient hub with external surface configurations for mounting in the mounting aperture of the holder. The non-patient needle assembly further includes a non-patient cannula extending proximally from the hub and a multiple sample sleeve telescoped over the non-patient cannula and mounted to the proximal end of the hub. The hub of the non-patient needle assembly can be threaded or otherwise engaged in the mounting aperture of the tube holder so that the non-patient needle and the multiple sample sleeve project into the tube receiving chamber of the holder.
• The blood collection set may be used by mounting the fitting at the proximal end of the flexible plastic tubing to the distal end of the hub of the non-patient needle assembly. The packaging shield that covers the non-patient cannula then may be removed, and the hub of the non-patient needle assembly may be engaged with the tube holder. The medical practitioner then grips the IV needle assembly and removes the packaging cover from the IV cannula. The gripping of the IV needle assembly may include folding the flexible wings into face-to-face engagement and gripping the folded wings between a thumb and forefinger. The pointed distal end of the IV cannula then is urged into a targeted blood vessel. The wings then may be folded into engagement with the skin of the patient and may be taped in position. An evacuated tube then is urged into the open proximal end of the blood collection tube holder so that the non-patient needle pierces the stopper of the evacuated tube. As a result, the blood vessel of the patient is placed in communication with the interior of the evacuated tube, and the pressure differential between the blood vessel and the evacuated tube will generate a flow of blood through the IV cannula, through the passage of the IV hub, through the flexible tubing, through the non-patient hub and finally through the non-patient needle and into the evacuated tube.
• The translucent or opaque plastic material of blood collection sets and IV cannula shields, combined with numerous cannula shield mechanism components and the length of the typical needle hub tends to inhibit a clear indication of venous or arterial access. Blood flow into the plastic tubing does provide an indication of venous or arterial access (known as “flash”) as the plastic tubing is often formed from a highly translucent or transparent plastic material. However, because of the existence of the elements associated with the IV needle assembly the length of flash obtained from a typical venous entry may not be sufficient for blood flow to be observed in the flexible tubing at a location proximal to the IV needle assembly itself. Thus, a medical practitioner may have a delayed indication of venous or arterial access and may incorrectly assume that the blood vessel was not accessed properly. In these situations, the medical practitioner may try to access the blood vessel again even though the initial access was successful. Accordingly, the patient may be subjected to unnecessary trauma during a repeated attempt to access the targeted blood vessel. Thus, improved techniques for increasing the length of flash such that initial blood flow will be observable in the flexible tubing proximal the IV needle assembly and associated shielding elements would be desirable.
SUMMARY OF THE INVENTION
• The invention relates to a blood collection set with an internal chamber provided to increase the internal volume of the blood collection set when compared to a prior art blood collection set which does not have an internal chamber. In this manner, improved flash visualization, can be provided.
• “Internal chamber” as used herein means an enclosed space or compartment, which is in communication with the fluid passage of the blood collection set. The “fluid passage” is defined as any part of the blood collection set in which blood flows and can include the lumen through the IV cannula, the passage through the IV hub, the passage through the flexible tubing, the passage through the non-patient hub and lumen through the non-patient cannula. “Flash” is defined as the initial blood flow into the fluid passage on venous entry, which provides an indication of venous or arterial access before an evacuated tube is urged into the open proximal end of the blood collection tube holder. “Flash length” is the linear distance that blood flows in a proximal direction along the fluid passage on venous entry. “Flash volume” is the volume of blood that flows into the fluid passage on venous entry expressed as a percentage of the total internal volume of the blood collection set.
• In one embodiment, the blood collection set includes an IV needle assembly, a length of flexible plastic tubing extending from the IV needle assembly and a non-patient needle assembly. The internal chamber is advantageously disposed on or near the non-patient needle assembly to permit an increase in the internal volume of the blood collection set without being located directly in the blood flow path.
• The IV needle assembly typically comprises an IV hub having a proximal end, a distal end and a passage extending between the ends. The IV needle assembly typically further comprises an IV cannula having a proximal end mounted in the passage of the IV hub, a pointed distal end projecting distally from the IV hub and a lumen that communicates with the passage through the IV hub. The flexible tubing is typically connected to the proximal end of the IV hub. The IV needle assembly typically includes a packaging cover that protectively encloses the IV needle cannula prior to use. The packaging cover is removed immediately prior to use to permit access to the IV cannula. The IV needle assembly may further include a protective shield that is moveable relative to the IV cannula from an open position where the IV cannula is exposed to a closed position where the IV cannula is substantially shielded. The shield protects against accidental sticks with the used IV cannula. A pair of flexible wings may be mounted to the IV hub or to the shield to facilitate manipulation of the IV needle assembly.
• In this embodiment, the non-patient needle assembly includes a non-patient hub having a proximal end and a distal end. The non-patient needle assembly further includes a non-patient cannula having a distal end securely mounted in the hub, a proximal end projecting proximally from the non-patient hub and a lumen that communicates with the passage through the non-patient hub. A multiple sample sleeve is typically mounted over the non-patient cannula and secured to the proximal end of the non-patient hub. External portions of the non-patient hub near the proximal end thereof may be formed with an array of external threads or other mounting structure to enable the non-patient needle assembly to be mounted to a collection tube holder or other such medical device. Or, the holder may be pre-attached with the non-patient needle assembly. The blood collection set may further include a fitting mounted to the proximal end of the flexible plastic tubing and configured for mating with the distal end of the non-patient hub. For example, the fitting may be a female luer fitting that can be engaged with the male luer taper at the distal end of the non-patient hub.
• In one embodiment, the internal chamber is located in the non-patient assembly beyond the non-patient cannula proximal end, which means that the air passes through the non-patient cannula proximal end from which blood is drawn, and then into the internal chamber. Specifically, on venous entry air is compressed and flows from the fluid passage and out of the non-patient cannula proximal end where it further flows through the space between needle exterior and multiple sample sleeve. The air then flows into the internal chamber, which may be at the non-patient barb, the non-patient hub thread, the non-patient hub body, or other location or combination of locations that are beyond the non-patient cannula proximal end. The collection tube, which is applied at the non-patient cannula proximal end, draws blood from only the fluid passage and not from the internal chamber.
• In another embodiment, a one-way check valve is located within the internal chamber. The valve allows air and blood to enter the internal chamber but shuts closed both when vacuum is applied. Thus, when an evacuated collection tube is applied at the non-patient needle tip, the tube draws blood from the fluid passage but not from the internal chamber, and upon removal of the IV needle from the targeted blood vessel, the check valve closes and inhibits blood from dripping from the IV needle tip.
• In a further embodiment, the internal chamber utilizes a branch in the fluid passage, e.g., a “Y” or “T”. The branching may be at any location or locations along the fluid passage, but is advantageously at the proximal end such as at the non-patient hub. The branching may be in the form of a separate component added into the fluid passage such as in between the female and male luer fittings or it may be integral within the hub. The branching includes some type of internal chamber as discussed herein.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A is a perspective view of a prior art blood collection set and collection tube holder.
• FIG. 1B is a top plan view of the blood collection set and collection tube holder shown inFIG. 1A.
• FIG. 2 is an exploded perspective view of a prior art blood collection set.
• FIG. 3 is side elevation view of a prior art non-patient needle assembly, partly in section.
• FIG. 4 is a cross-sectional side view of an embodiment of the non-patient needle assembly of the blood collection set.
• FIG. 5 is a perspective view of the same embodiment shown inFIG. 4
• FIG. 6 is a cross-sectional side view of an embodiment of the non-patient needle assembly of the blood collection set.
• FIG. 7 is a perspective view of the same embodiment shown inFIG. 6
• FIG. 8 is a cross-sectional side view of an embodiment of the non-patient needle assembly of the blood collection set.
• FIG. 9 is an expanded view of the same embodiment shown inFIG. 8
• FIG. 10 is a perspective view of one embodiment of a one way check valve.
• FIG. 11 is a plan view of the same embodiment shown inFIG. 10
• FIG. 12 is a cross-sectional side view of the same embodiment shown inFIG. 10
• FIG. 13 is a perspective view of one embodiment of the blood collection set.
• FIG. 14 is a perspective view of one embodiment of the blood collection set.
DETAILED DESCRIPTION
• A prior art blood collection set that contains IV cannula shielding is identified generally by the numeral10 inFIGS. 1A and 1B. Blood collection set10 is employed in this embodiment with acollection tube holder12.Holder12 has aproximal end14, adistal end16 and atubular sidewall18 extending between the ends.Proximal end14 ofholder12 is widely open and defines an entry to a tube receptacle withinsidewall18. Thus, an evacuated collection tube can be slid in a proximal-to-distal direction through openproximal end14 ofholder12 towarddistal end16.Distal end16 ofholder12 is characterized by anend wall20.End wall20 is formed with an internally threaded mountingaperture22, as shown inFIG. 3.
• Blood collection set10 includes anIV needle assembly24 that comprises anIV hub26.IV hub26 includes aproximal end28, adistal end30 and a passage (not shown) extending between the ends.IV needle assembly24 further includes anIV cannula32 with aproximal end34, a pointeddistal end36 and alumen38 extending between the ends.Proximal end34 ofIV cannula32 is mounted securely in the passage ofIV hub26. Thus,lumen38 throughIV cannula32 communicates with the passage throughIV hub26.Flexible wings40 are mounted toIV hub26 at a location neardistal end30.Wings40 can be folded into face-to-face relationship with one another for convenient gripping between a thumb and forefinger to enable manipulation ofIV needle assembly24.Wings40, however, also can be rotated into a substantially coplanar disposition for taping to the skin of a patient.
• IV needle assembly24 further includes atubular shield42 that is telescoped overIV hub26.Shield42 is formed withtransverse slots44 that slidably receivewings40. Thus, shield42 can be slid from a proximal position, as shown inFIGS. 1A and 1B to a distal position.IV cannula32 is exposed for use whenshield42 is in the proximal position shown inFIGS. 1A and 1B. However,IV cannula32 is substantially surrounded byshield42 whenshield42 is moved to the distal position. Additionally,slots44 inshield42 are configured to lockingly engagewings40 whenshield42 is in the distal position to prevent or complicate a re-exposure ofIV cannula32. In this case the presence of a shield does not inhibit flash visualization within the IV needle assembly. The shield illustrated inFIGS. 1A and 1B is one of many optional shield designs that can be incorporated into blood collection set10. Other designs may provide wings mounted directly to the shield. Still other designs may provide a hinged shield mounted toIV hub26. In still other designs, a shield may be entirely separate fromIV needle assembly24.
• Another prior art blood collection set is identified generally by the numeral110 inFIG. 2. Fluid collection/infusion set110 includes a length of flexibleplastic tubing112, aproximal fitting114, aneedle assembly116, aspring118 and a barrel assembly that comprises afront barrel120, arear barrel122 and awing124.Needle assembly116 includes aneedle cannula134, aneedle hub136 and a needle protector.138.Needle cannula134 has aproximal end140, adistal end142 and a lumen144 extending between the ends.Distal end142 ofneedle cannula134 is beveled to a sharp tip.
• FIGS. 1A and 1B also show that a blood collection set10 further includes a length of flexibleplastic tubing46.Tubing46 includes opposite proximal anddistal ends48 and50 and a passage extending between the ends.Distal end50 oftubing46 is securely mounted toproximal end28 ofIV hub26 so that the passage throughIV hub26 communicates with the passage throughtubing46. A female luer fitting52 is securely mounted toproximal end48 oftubing46.
• Blood collection set10 further includes anon-patient needle assembly54, as shown inFIG. 3.Non-patient needle assembly54 includes anon-patient hub56 with aproximal end58, adistal end60 and afluid passage62 extending between the ends. Exterior surface regions ofnon-patient hub56 substantially adjacentproximal end58 define an array ofexternal threads64 configured for threaded engagement with the internal threads formed in mountingaperture22 ofcollection tube holder12. External surface regions ofnon-patient hub56 adjacent distal end define amale luer taper66 configured for mating with female luer fitting52.Non-patient needle assembly54 further includes anon-patient cannula68 having a pointedproximal end70, adistal end72 and alumen74 extending between the ends.Distal end72 ofnon-patient cannula68 is mounted securely inpassage62 throughnon-patient hub56 and aligns substantially withexternal threads64 onnon-patient hub56.Non-patient needle assembly54 further includes amultiple sample sleeve76 mounted overnon-patient cannula68 and securely engaged withproximal end58 ofnon-patient hub56.Multiple sample sleeve76 effectively functions as a valve that prevents a flow of fluid fromnon-patient cannula68. However,multiple sample sleeve76 can be pierced by pointedproximal end70 ofnon-patient cannula68 in response to forces generated by a stopper on an evacuated collection tube.
• It should be noted that flash visualization maybe acceptable in certain blood collection sets with safety features, such as the type shown inFIGS. 1A and 1B. The IV needle assembly and safety shield tend to be made from a translucent plastic material, and may only contain the IV cannula and flexible tubing, which may allow flash to be seen through the IV cannula hub walls. Therefore a minimum length of flash maybe sufficient, such that initial blood flow on venous entry maybe observed at the proximal end of the IV cannula. However in more advanced and complex IV cannula shielding mechanisms, such as the blood collection set shown inFIG. 2, the length of flash obtained from a typical venous entry may not be sufficient for blood flow to be observed in the flexible tubing at a location proximal to the IV needle assembly itself, therefore flash visualization tends to be inhibited within the IV needle assembly.
• According to one embodiment of the invention, a blood collection set, for example of the type disclosed above, contains an internal chamber that increases the internal volume of the blood collection set. The increase in internal volume of the blood collection set provides a greater length of flash and therefore improved flash visualization, such that, advantageously, blood is observed in the flexible tubing proximal the IV needle assembly on the initial venous entry. While such improved or lengthened flash is particularly advantageous for such complex blood collection sets as shown inFIG. 2, application in any blood collection set is contemplated.
• According to this embodiment of the invention, a blood collection set includes a plurality of internal spaces that will initially be at ambient air pressure. These internal spaces include the lumen through the IV cannula, the passage through the IV hub, the passage through the flexible tubing, the passage through the non-patient hub and lumen through the non-patient cannula. The blood collection set is employed by folding wings into face-to-face engagement with one another and gripping the wings between a thumb and forefinger. Any packaging cover that may be mounted over IV cannula then is removed and discarded. The pointed distal end of the IV cannula then is urged into a targeted blood vessel. The healthcare practitioner then may release the grip on the wings, and if long term access to the blood vessel is required, the wings may be taped into face-to-face engagement with the skin of the patient. The venous or arterial access achieved with the IV cannula places the plurality of interior spaces of the blood collection set in communication with the pressure of the blood in the patient. Blood pressure exceeds the ambient air pressure. Accordingly, the pressure of air in the above-referenced internal spaces will increase, and blood will begin to flow into these internal spaces. The system will reach equilibrium as the air pressure within the blood collection set increases in response to a reduction of volume caused by the inflow of blood. Hence, a portion of the internal spaces in the system will remain filled with air at a pressure substantially equal to the venous or arterial pressure thereby preventing blood from flowing any further to or into the tubing. Stated differently, the system will include its original volume of air in the space between the proximal end of the non-patient needle and the blood that enters the blood collection set. This pressurized air will prevent any further flow of blood toward the non-patient assembly, thereby stopping flash. In prior art systems the total volume of the internal spaces maybe insufficient, such that flash maybe stopped before it can be observed. According to embodiments of the invention, however, the internal chamber which lacks direct communication to the exterior, provides more internal volume into which the air can be pushed, allowing blood to push further into the device before the pressure of the blood equals the pressure of the air. This increase in interior space thereby allows a greater length of flash to occur. Various embodiments of such internal chambers are described in detail below.
• FIGS. 4 and 5 show an embodiment of the invention, where theinternal chamber301 is located beyond theproximal end370 of the non-patient cannula in thenon-patient hub356 and lacks direct communication to the exterior. Theinternal chamber301 is annular in cross-section and has opposite proximal770 anddistal ends771 and awall772 extending therebetween; theproximal end770 has aninlet777 in communication with the passage. However all internal chamber geometries can be considered for the invention. Thenon-patient hub356 is generally made from 2 separate parts; themale luer374 and thenon-patient thread assembly375. Other configurations are possible. On venous entry, air is compressed and flows from thefluid passage362 and out of the non-patient cannulaproximal end370 where it further flows through thespace312 betweenneedle exterior368 and multiplesample sleeve interior376, then through apassage314 through the non-patient barb and themale luer wall320 into theinternal chamber301 through theinlet777 in themale luer374.
• FIGS. 6 and 7 show another embodiment of the invention, with an elongated internal chamber to further increase the flash length. Theinternal chamber301ais annular in cross-section and has opposite proximal770aanddistal ends771aand awall772aextending therebetween, theproximal end770ahas aninlet777ain communication with the passage. However all internal chamber geometries can be considered for the invention. The non-patient hub is made from 2 separate parts; themale luer374aand thenon-patient thread assembly375a.The longerinternal chamber301ais located beyond theproximal end370aof the non-patient cannula in thenon-patient thread assembly375aand has no direct communication to the exterior. Other configurations are possible. On venous entry, air is compressed and flows from thefluid passage362aand out of the non-patient cannulaproximal end370awhere it further flows through thespace312abetween needle exterior368aand multiple sample sleeve interior376a,then through apassage314athrough the non-patient barb into aninternal chamber301athrough aninlet777ain thenon-patient thread assembly375a.
• FIGS.8 to12 show a further embodiment of the invention, in which a one-way valve555 is located within an internal chamber similar to that shown inFIG. 6. The one way valve has acentral core550 surrounded by anannular flange551 that has asealing ring552 around its outer diameter. Thecentral core550 is located around thenon-patient needle exterior368bwithin theinternal chamber301band has a taperedbase553 which mates to the taper ofinlet777b.Typically the oneway valve555 is formed from a resilient polymer such as an elastomer or thermoplastic.
• As apparent to one skilled in the art, on venous entry, air flows from thefluid passage362band out of the non-patient cannulaproximal end370bwhere it further flows through thespace312bbetweenneedle exterior368band multiplesample sleeve interior376b,then through apassage314b,through the non-patient barb and the male luer wall320b,through theinlet777bwhere it moves the one-way valve555, flowing past thevalve core base553,valve sealing ring552 and into aninternal chamber301bin themale luer374b.A vacuum is applied to the fluid passage, when an evacuated collection tube is applied at the non-patient needle tip. The resultant positive pressure differential between the internal chamber and the fluid passage causes the oneway valve555 to close, by thevalve sealing ring552 being pressed against the proximal end of theinternal chamber770band the valve core taperedbase553 being pressed intoinlet777bthereby preventing outflow of air or blood from the internal chamber. It should be noted that the one way valve is not limited to the particular design described in this embodiment as all types of one way valves can be contemplated for this invention.
• The oneway valve555 also inhibits blood from dripping from the IV needle tip upon removal of the IV needle from the targeted blood vessel after the blood collection has been completed. In prior art blood collection sets, at the instance of removal of the IV needle, the fluid passage of the blood collection set, will contain a reservoir of air and blood at venous pressure, which will be greater than the ambient atmospheric pressure. Thus a back pressure is created within the fluid passage which may cause a back-flow of blood to drip from the IV needle tip. In the embodiment of the invention shown in FIGS.8 to12, the reservoir of air at venous pressure is within theinternal chamber301b,therefore the back pressure causes the oneway valve555 to shut upon removal of the IV needle thereby preventing such a back-flow of blood in thefluid passage362b.
• FIGS. 13 and 14 show another embodiment of aninternal chamber401 which is branched from the fluid passage using a “Y” or “T” branched internal chamber in the fluid passage into which air is displaced. The branching may be at any location or locations along the fluid passage, but is typically near the proximal end such as at the non-patient hub.FIG. 13 shows a “Y” branchedinternal chamber454 in the form of a separate component added into thefluid passage462 such as in between the female455 andmale luer456 fittings.FIG. 14 shows a “T” branchedinternal chamber457, which is an integral part of the non-patient hub, thus reducing the number of components. The use of a “Y” or “T” branched internal chamber may be accomplished with any convenient terminal shapes at the interfaces of each component. The embodiments exemplified previously are shown with luer tapered fittings but other interface designs such as direct connection to the flexible tubing may also be applied. Although typical applications use a three port “Y” or “T” branched internal chamber the use of a multiple port branched internal chamber system is also possible. Theinternal chamber401, can be a separate component which is affixed into aport460 of the branch system as shown inFIG. 13 or an integral part of the branched system as shown inFIG. 14. All internal chamber geometries can also be contemplated.

Claims (13)

1. A blood collection set comprising;

a first needle assembly comprising a first hub and a first cannula having a lumen therethrough, wherein said cannula is mounted to said first hub,

a length of flexible tubing having opposite first and second ends and a tubing passage extending between said ends, said first hub located proximate said first end for providing communication between said lumen of said first cannula and said tubing passage,

a second hub located proximate said second end and having a passage extending therethrough, said second hub passage being in fluid communication with said tubing passage,

a non-patient cannula having opposite proximal and distal ends and a lumen extending between said ends, said distal end of said non-patient cannula being mounted to said second hub such that said lumen through said non-patient cannula communicates with said second hub passage,

a multiple sample sleeve covering said non-patient cannula and mounted to said second hub, and

an internal chamber in communication with said second hub passage, wherein said internal chamber is located within said second hub or is branched from said second hub passage, and wherein said internal chamber lacks direct communication to the exterior.

2. The blood collection set ofclaim 1, wherein said second hub further comprises a male luer and a non-patient thread assembly, which form said internal chamber.

3. The blood collection set ofclaim 1, wherein said internal chamber communicates with said second hub passage beyond said proximal end of said non-patient cannula.

4. The blood collection set ofclaim 1, further comprising a one way valve, wherein said one way valve inhibits an outflow of air or fluid from said internal chamber.

5. The blood collection set ofclaim 4, wherein said one way valve is located within said internal chamber.

6. The blood collection set ofclaim 1, wherein upon venous access by said first needle cannula, venous pressure causes blood to flow into said tubing passage, such that the total internal volume of said internal chamber and tubing passage results in a flash length of at least approximately 0.25 inches in linear distance in a proximal direction along said tubular passage from said first end of said flexible tubing.

7. The blood collection set ofclaim 1, wherein upon venous access by said first needle cannula, venous pressure causes blood to flow into said tubing passage, such that the total internal volume of said internal chamber and tubing passage results in a flash length of at least approximately 0.50 inches in linear distance in a proximal direction along said tubular passage from said first end of said flexible tubing.

8. The blood collection set ofclaim 1, wherein said internal chamber is branched from said second hub passage.

9. The blood collection set ofclaim 8, wherein said internal chamber is a Y branched internal chamber or a T branched internal chamber.

10. The blood collection set ofclaim 1, wherein the volume of said internal chamber is at least approximately 1.0 ml.

11. The blood collection set ofclaim 10, wherein said volume of said internal chamber is approximately 1.0 ml to approximately 3.0 ml.

12. The blood collection set ofclaim 11, wherein said volume of said internal chamber is approximately 1.0 ml to approximately 2.0 ml.

13. A blood collection set comprising;

a first needle assembly comprising a first hub and a first cannula having a lumen therethrough, wherein said cannula is mounted to said first hub,

a length of flexible tubing having opposite first and second ends and a tubing passage extending between said ends, said first hub located proximate said first end for providing communication between said lumen of said first cannula and said tubing passage,

a second hub located proximate said second end and having a passage extending therethrough, said second hub passage being in fluid communication with said tubing passage,

a non-patient cannula having opposite proximal and distal ends and a lumen extending between said ends, said distal end of said non-patient cannula being mounted to said second hub such that said lumen through said non-patient cannula communicates with said second hub passage,

a multiple sample sleeve covering said non-patient cannula and mounted to said second hub, and

an internal chamber in communication with said second hub passage, wherein said internal chamber is located within said second hub or is branched from said second hub passage, and wherein said internal chamber lacks direct communication to the exterior, wherein upon on venous access by said first needle cannula, venous pressure causes blood to flow into said tubing passage such that the total internal volume of said internal chamber and tubing passage results in flash being observed within said flexible tubing.

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